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| ID | Type | Description | Link |
|---|---|---|---|
| U01AI138897 | U.S. NIH Grant/Contract | View source | |
| RTB-024 | Other Identifier | The National Institute of Allergy and Infectious Diseases (NIAID) |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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This research is being done to better understand opportunistic infections and cancer in transplant recipients with HIV who receive livers from a donor with HIV compared to livers from donors without HIV.
Previously, people with HIV in need of a transplant could only receive organs from a donor without HIV. However, in November 2013, the HIV Organ Policy Equity (HOPE) Act made it possible for people with HIV to receive organs from donors with HIV as a part of a research study.
Over the last two decades, people with HIV have received organs from donors without HIV, and in general, these recipients have done well after transplant and still maintained control of HIV. Over the last several years, people with HIV have received organs from donors with HIV, and in general, these recipients have also done well after transplant and still maintained control of HIV. Although organ transplant into people with HIV using donors with and without HIV has been successful, the use of organs from donors with HIV may increase the risk of certain opportunistic infections and cancer in some people. Opportunistic infections are when pathogens (germs) cause infections in people with weakened immune systems that would not happen, or would be mild, in people with healthy immune systems. This study will look to better understand opportunistic infections and cancer in transplant recipients with HIV (HIV R+) who receive livers from donors with HIV (HIVD+) or without HIV (HIV D-).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV D+/R+ | Experimental | People living with HIV who receive livers from deceased donors with HIV |
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| HIV D-/R+ | Experimental | People living with HIV who receive livers from deceased donors without HIV |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIV D+/R+ | Other | Receipt of liver transplant from a deceased donor with HIV |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of a composite event of opportunistic infection or cancer in HIV D+/R+ compared to HIV D-/R+ LT | Cumulative incidence of composite event of opportunistic infection or cancer | From transplant through end of follow up (at least 6 months year, up to 4 years post-transplant) |
| Measure | Description | Time Frame |
|---|---|---|
| Participant survival | Time to event (death) | From transplant through end of follow up (at least 6 months, up to 4 years post-transplant) |
| Graft survival | Time to event (graft loss) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christine Durand, MD | Contact | 410-614-6702 | ChristineDurand@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Christine Durand, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic, Arizona | Phoenix | Arizona | 85054 | United States |
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| HIV D-/R+ |
| Other |
Receipt of liver transplant from a deceased donor without HIV |
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| From transplant through end of follow up (at least 6 months, up to 4 years post-transplant) |
| Incidence of bacterial, fungal, viral, and other opportunistic infections post-transplant | Cumulative incidence of infections | From transplant through end of follow up (at least 6 months, up to 4 years post-transplant) |
| Incidence and type of post-transplant cancer as determined by local pathology | Cumulative incidence of cancer determined by local pathology | From transplant through end of follow up (at least 6 months, up to 4 years post-transplant) |
| Serious adverse events post-transplant | Cumulative incidence of serious adverse events | From transplant through end of follow up (at least 6 months, up to 4 years post-transplant) |
| Incidence of rejection events post-transplant | Cumulative incidence of rejection events | From transplant through end of follow up (at least 6 months, up to 4 years post-transplant) |
| Graft function over time measured by fibrosis-4 index and Aspartate Aminotransferase (AST) to Platelet Ratio Index | Mean value of graft function | From transplant through end of follow up (at least 6 months, up to 4 years post-transplant) |
| Incidence of HIV-breakthrough and HIV persistent viral failure post-transplant | Cumulative incidence of HIV-breakthrough and HIV persistent viral failure | From transplant through end of follow up (at least 6 months, up to 4 years post-transplant) |
| Incidence of new antiretroviral drug resistance and/or X4 tropic virus post-transplant | Cumulative incidence of new resistance and/or X4 tropic virus based on local testing | From transplant through end of follow up (at least 6 months, up to 4 years post-transplant) |
| Incidence of surgical and vascular transplant complications during the first year post-transplant | Cumulative incidence of complications | From transplant through end of follow up (at least 6 months year, up to 4 years post-transplant) |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
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| University of California, San Francisco | San Francisco | California | 94143 | United States |
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| University of Colorado Anschutz | Aurora | Colorado | 80045 | United States |
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| Mayo Clinic, Florida | Jacksonville | Florida | 32224 | United States |
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| University of Miami, Miami Transplant Institute | Miami | Florida | 33136 | United States |
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| Emory University | Atlanta | Georgia | 30322 | United States |
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| Northwestern University | Chicago | Illinois | 60611 | United States |
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| Ochsner Clinic Foundation | Jefferson | Louisiana | 70121 | United States |
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| Johns Hopkins University | Baltimore | Maryland | 21205 | United States |
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| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| New York University School of Medicine | New York | New York | 10016 | United States |
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| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
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| Weill Cornell Medical College | New York | New York | 10065 | United States |
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| University of Cincinnati | Cincinnati | Ohio | 45229 | United States |
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| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
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| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15224 | United States |
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| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
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| Houston Methodist Research Institute | Houston | Texas | 77030 | United States |
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